Received Aug 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | F95YS | IM / LA |
sore shoulder; rash on back; The patient reported that because of the rash he researches more about the vaccine and that was when he found out about the warning of not shaking vigorously.; This non-serious case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number F95YS, expiry date 31-MAR-2027) for prophylaxis. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and paracetamol (Tylenol). On 23-JUN-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. On 23-JUN-2025, an unknown time after receiving Shingrix, the patient experienced wrong technique in product usage process (Verbatim: The patient reported that because of the rash he researches more about the vaccine and that was when he found out about the warning of not shaking vigorously.). In JUL-2025, the patient experienced rash (Verbatim: rash on back). On an unknown date, the patient experienced shoulder soreness (Verbatim: sore shoulder). The patient was treated with hydrocortisone. Rechallenge with Shingrix was positive. The outcome of the shoulder soreness and rash were unknown and the outcome of the wrong technique in product usage process was not applicable. It was unknown if the reporter considered the shoulder soreness and rash to be related to Shingrix. It was unknown if the company considered the shoulder soreness and rash to be related to Shingrix. Linked case(s) involving the same patient: US-GSK-US2025098396 Additional Information: GSK Receipt Date: 25-JUL-2025 The reporter was the patient. He stated that when the 2nd dose was administered, he saw how the vials were mixed. He reported the person that gave it to hm shook it very vigorously and reacted to it, which led to wrong technique in device usage process. Gently swirl the vial until powder was completely dissolved. Did not shake vigorously vaccination it was sent to the public health service of region. He reported after the second dose having a sore shoulder and reports a month later he developed a rash on his back. He believes the rash was related to heat and sweat. He used topical Hydrocortisone cream. The patient reported that because of the rash he researches more about the vaccine and that was when he found out about the warning of not shaking vigorously. No additional information was provided. For tolerance of 1st dose refer case US2025096373.; Sender's Comments: US-GSK-US2025096373:Same patinet dose 1st
SHINGRIX; TYLENOL